Local Anesthesia With Schelin Catheter in Rezum Treatment: a Randomized Controlled Trial (LOCALVAPOR)
Study Overview
Status
Conditions
Detailed Description
Benign prostatic hyperplasia (BPH) is a common age-related pathology, affecting almost one in three men over the age of 50. It is responsible for voiding disorders in men, which can significantly impair quality of life. Briefly, drug treatment is currently used as first-line therapy; in the event of primary or secondary failure, surgery may be indicated. Over the past 25 years, a number of minimally invasive surgical therapies (MIST) have been developed for the treatment of male voiding disorders associated with BPH. MIST should enable rapid and lasting improvement in symptoms and quality of life, preservation of sexual function in contrast to conventional surgical techniques, rapid return to normal daily activity, and a minimal side-effect profile, thus enabling outpatient management. One of the many advantages of these techniques is to avoid the need for general anaesthesia, both for the growing cohort of elderly patients and for younger patients wishing to return to work quickly. In its pilot study, water vapor thermal therapy (RezumTM, Boston Scientific Corporation, Marlborough, MA) was proposed as a minimally invasive procedure, but often requiring oral ± intravenous sedation or a transrectal prostatic block. Therefore, pain management during Rezum therapy remains a challenge and may lead to the use of pain control protocols and general anesthesia, in some ways limiting the concept of a minimally invasive ambulatory surgery approach. In addition, the use of general anesthesia requires the presence of a dedicated anesthesia team, and adds to the burden of the patient journey (pre-operative anesthesia consultation, exposure to anesthetic drugs, passage to recovery room, slower post-operative recovery). From a surgical point of view, recourse to general anesthesia during Rezum treatment adds to an already saturated operative schedule, with significantly increased room occupancy time, for a Rezum therapy whose average operating time is 5 minutes. The Schelin® catheter (ProstaLund AB, Lund, Sweden), approved by the European Medicines Agency, is a device for injecting analgesic drugs directly into the prostate via the transurethral route, providing more effective local anesthesia and avoiding the need for transrectal or general anesthesia. This catheter is therefore of crucial use in offering our patients an ultra-minimally invasive treatment, which can be associated with a reduction in room occupancy time, time spent in outpatient surgery, a procedure performed independently of the anesthesia team, and for the patient, an accelerated post-operative recovery.
By delivering the Rezum treatment via the Schelin catheter, our hypothesis is a significant reduction (>20%) in room occupancy time in the operating room, associated with accelerated post-operative recovery for the patient.
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Michael Baboudjian, MD
- Phone Number: 04.91.96.87.18
- Email: michael.baboudjian@ap-hm.fr
Study Locations
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Marseille, France, 13015
- Recruiting
- Service d'urologie, Hôpital Nord (AP-HM)
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Contact:
- Michael Baboudjian, MD
- Phone Number: +33 4 91 96 87 18
- Email: michael.baboudjian@ap-hm.fr
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Patients referred for symptomatic benign prostatic hyperplasia (BPH)
- Men between 45 and 80 years of age
- IPSS > 13
- Qmax <15 ml/s
- Prostate volume between 30 and 80 g on ultrasound
- Patient able to understand study details, benefits and risks
- Patient able to give informed consent
- Beneficiary of or affiliated to the French social security system
- Patient having signed an informed consent form
Exclusion Criteria:
- Patients with a history of prostate cancer
- Patient with history of BPH surgery
- Patients with a history of neurological bladder disease
- Patient with history of urethral stricture
- Patient with history of penile implants
- Patient with history of pelvic irradiation
- Patient with a symptomatic urinary tract infection in the 10 days prior to surgery
- Presence of bladder stones on ultrasonography
- Patient allergic to lidocaine 2% or any medication used in the pre-operative protocol (anxiolytics, analgesics and non-steroidal anti-inflammatory drugs)
- Patient under guardianship or curatorship
- Protected patient, deprived of liberty
- Patient with a neurological and/or psychiatric disorder making it impossible to understand the terms of the study and to sign an informed consent form
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
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Active Comparator: general anesthesia
REZUM procedure under general anesthesia
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Water vapor procedure will be performe under conscious intravenous sedation with anesthesia team
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Active Comparator: Local anesthesia
REZUM procedure under local anesthesia
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Water vapor procedure will be performe under local anethesia administrated with Schelin® catheter via the trans-urethral route : injection of 20cc of lidocaine 2% intra-prostatically via the schelin catheter at 4 injection points (3cc at 1h, 3cc at 11h, 7cc at 4h, and 7cc at 8h).
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Comparison of the operating room occupancy time between the 2 groups
Time Frame: Visit 2: surgery
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Operating room occupancy time during REZUM procedure
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Visit 2: surgery
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Comparison of the quality of recovery after surgery between the 2 groups
Time Frame: 24h after surgery
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Quality of recovery-15 scores (QoR-15)
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24h after surgery
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Comparison of the pain post-surgery between the 2 groups
Time Frame: 1 hour, 2 hours and 24 hours after surgery
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Numerical pain rating scale (0-10)
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1 hour, 2 hours and 24 hours after surgery
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Success rate of the local anesthesia for the REZUM procedure
Time Frame: intraoperative
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intraoperative
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Comparison of functional results between the 2 groups
Time Frame: 3 months post-surgery
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urinary function assessment:
Sexual function assessment:
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3 months post-surgery
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Comparison of the average number of side-effects post-surgery between the 2 groups
Time Frame: 30 days post-surgery
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Post-operative side effects reported using the Clavien-Dindo classification
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30 days post-surgery
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Collaborators and Investigators
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- RCAPHM24_0263
- 2024-A01800-47 (Other Identifier: ANSM)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
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